Sunday, April 26. 2009

By Keri Sutherland and Jan DisleyLast updated at 2:17 AM on 26th April 2009

A bereaved mother has criticised a Government watchdog which has only just advised against children being given a pain-relieving teething gel – 23 years after her baby was given the treatment and later died.

More than two decades ago, The Mail on Sunday campaigned to stop children using Bonjela, which has been linked to a potentially fatal disease.In 1986, we told how Anne Backhouse believed her son Nickolas contracted Reye’s Syndrome, which can lead to a serious liver and brain disease, after she used Bonjela to soothe his painful gums.

Nickolas fell seriously ill with a viral infection, later suffering liver and brain damage leading to his eventual death seven years later. Speaking last week from her home in Warrington, Cheshire, Mrs Backhouse said: ‘I was calling for these treatments to be taken off the shelves in the Eighties. How come it has taken so long?’

Following the MoS campaign, the Government banned children from taking Junior Aspirin and Junior Disprin in which salicylate salts, linked to Reye’s Syndrome, are present.

Yet, despite warnings from health experts, no recommendations were made about the use of Bonjela – which also contains salicylate salts.But now the Medicines And Healthcare Products Regulatory Authority (MHRA) warns Bonjela should not be administered to children, after it received a series of complaints.

The watchdog said seven children had recently fallen ill after using Bonjela or Bonjela Cool mint gel but had since recovered and none were confirmed cases of Reye’s Syndrome.

Mrs Backhouse, 55, said the new advice had left her devastated as to why her ordeal was ‘brushed under the carpet’. She said: ‘What has changed? What did people really know 23 years ago? I want answers. They told me back then it was perfectly safe. Did they think I’d forget?’

In April 1986, Nickolas was treated with antibiotics after falling ill with a chest infection. His mother says until that time only milk, water and Bonjela – used to ease his painful gums – had passed her son’s lips. Medical experts are still unsure how Reye’s Syndrome is contracted but evidence suggests it occurs in children who have taken salicylate salts in medicines while suffering from viral illnesses such as flu or chicken pox.

Within hours of a visit to the doctor’s, Nickolas became ‘blank’ and rigid before having violent convulsions. He spent nine days in an intensive care unit at Alder Hey Children’s Hospital in Liverpool.

Mrs Backhouse said: ‘He had massive brain damage, couldn’t use his arms or legs and had epilepsy.’But it wasn’t until she contacted the National Reye’s Syndrome Foundation that a possible link emerged between salicylate salts in Bonjela and her son’s illness.

At the time, Bonjela manufacturer Reckitt Benckiser Healthcare insisted the product was safe. In 1993, Nickolas fell ill with pneumonia and died in his mother’s arms. There was no inquest.

Mrs Backhouse says there was only one type of Bonjela available when she bought it for her son more than two decades ago. In 2002, Bonjela Teething Gel – which does not contain salicylates – was introduced for young children.

Today, the products affected by the warning are Bonjela and Bonjela Cool Mint Gel.

Last week, the MHRA said the advice was a ‘precautionary measure’.

Dr June Raine, a MHRA director, said: ‘Any risk from these oral gel products is theoretical. We are not aware of any confirmed cases but when there are alternatives available any risk is not worth taking.’

A spokeswoman for Reckitt Benckiser said she was aware of a case in 1986 but refused to confirm if it was Nickolas Backhouse.She added: ‘The MHRA has said that there have been no confirmed cases of Reye’s Syndrome associated with Bonjela/Bonjela Cool.

‘It is important to note that a report of a suspected or serious adverse drug reaction does not necessarily mean that Reye’s Syndrome was caused by the drug.’

Gordon Denney, of the National Reye’s Syndrome Foundation, said: ‘There is always a danger where salicylate salts are involved and salicylates are involved in Bonjela.’

Note: It took 28 years for the MHRA to issue warnings about tranquillisers. By that time thousands of lives had been ruined and stayed that way.